About us
Aminolab Ltd. was established on 1987, with the goal of delivering a wide range of analytical laboratory services, with uncompromising quality and reliability.
Aminolab laboratories follow either ISO/IEC 17025 or GLP (Good Laboratory Practice) guidelines, in accordance with the customer`s desire.
Aminolab is divided into several laboratories. Each laboratory specializes in a particular analytical field, and these are described below
Our services include analysis in the areas of: pharmaceuticals, biotechnology, environmental care, pesticides residues,food, medical devices and cosmetics.
Aminolab’s food laboratory is the leading laboratory in Israel in this field. The laboratory`s professional team provides a total chemical and biological support package for the food industry. All the analyses of food products are performed in-house. Three categories of food analysis are available: food safety, food composition and food additives.
A partial list of the types of food being analyzed include:
Fresh animal products: meat, chicken, fish, milk and milk products.
Fresh agricultural produce: grains, cereals, fruits and vegetables.
Processed foods: canned and frozen food; Baby food, dry fruit products and organically grown food.
For more details on food analysis please contact us:
Tel: 972-8-9303321
Fax: 972-8-9303300
marketing@aminolab.net
The Chemistry and Environmental Chemistry Department, headed by Dr. Zadok Shabi, is the largest department at Aminolab. The department provides analytical laboratory services in the fields of environmental care: water, wastewater, sludge, soil and air. Among our customers are the “Israeli Ministry of The Environment”, engineering companies, consulting & manufacturing companies.
Services provided include professional sampling and sample pick-up. A wide variety of analyses according to EPA and Standard Methods are available, as well as professional support.
A partial list of the matrixes we analyze are:
Water, treated wastewater, municipal and industrial waste,
contaminated soils, sludge, treated soil, filters, adsorption tubes, impingers and tedlar bags.
Contact Details:
Dr. Zadok Shabi
Tel: 972-8-9303351
Fax: 972-8-9303350
shabi@aminolab.net
Mr. Uri Golner has headed the Pesticide Residues department in Aminolab since 1996.
Uri joined Aminolab after acquiring 25 years of experience in the pesticides residues area at the Plant Protection and Inspection Services of the `Israeli Ministry of Agriculture`.
Aminolab provides analyses of pesticides residues in wide range of matrices such as: Fruits & vegetables, soil and water.
Also provided are analysis in organic and biological products, which require lower limits of detection - these abilities are made possible by using state of the art GC-MS/MS instrumentation.
The Pesticides Residues department is accredited since 1996 under ISO 17025 by the `Israel Laboratory Accreditation Authority` for various food commodities, soils and water, and is also certified for Pesticides Residues analysis in fruits and vegetables by the `Ministry of Health`.
The analyses are performed following FDA, AOAC and/or EPA methods, using GC-MS, GC-MS/MS and LC-MS detection systems. The department also performs analyses according to customer needs using instrumentation such as HPLC and ion chromatography. Commodities analyzed in Aminolab include: Fresh food (from import, export and local market), fruit, vegetable, milk products, fish, juice, baby food, grains, animal feed, water, soil, organic and biological materials and many others.
Contact details:
Mr. Uri Golner
Tel: 972-8-9303364
Fax: 972-8-9303366
uri@aminolab.net
Aminolab’s microbiology department performs microbiological analyses of medical devices and drugs under GLP guidelines.
In January 2000 the department was certified by the European Union (EU) and by the `Israel Laboratory Accreditation Authority` (ISRAC) as a GLP laboratory.
The certification includes Analytical Chemistry and Test for Microbial Contamination as well as safety and sterility analysis of medical devices.
A partial list of the analyses performed are: Sterilization validation (steam, EtO and radiation), Sterility test, Shelf life studies including sterility integrity of packaging after accelerated and natural aging.
The laboratory also performs routine analyses such as: Bioburden, Pyrogenicity (LAL), cleaning validation, Microbial barrier evaluation, Antimicrobial preservatives efficacy – challenge test, Microbial limit test, Antimicrobial activity of disinfectants and antiseptics, Environmental control- airborne and surface viable count as well as water system monitoring.
State of the art equipment includes:
Class 10,000 clean room, Temperature-Humidity controlled incubators, autoclaves, biohazard laminar flows, kinetic turbimetric LAL reader, Steritest, Airborne viable counter, Water filtration manifolds, and others.
The laboratory analyses are performed according to international certifications accepted in Europe and USA following the standards used in the industry.The department has performed analyses for Israeli companies that were accepted by the FDA and other international regulatory authorities.
Among the various devices analyzed in the laboratory are:
Syringes, dental implants, catheters, contact lenses, stents, pads, tubing as well as drugs, raw materials for the pharmaceutical industry and a wide range of additional products.
Contact details:
Dr. Tatiana Shub (deputy)
Tel: 972-8-9303331
Fax: 972-8-9303330
tatiana@aminolab.net
As part of the services for the cosmetic field, Aminolab submits application requests for new and imported cosmetic products, for certification with the Israeli Ministry of Health. Aminolab performs the entire application process from beginning to end: performing the chemical and biochemical required analysis, preparation and submission of the file to the `Ministry of Health`, and follow-up of the progress of the certification process at the health department - until certification is issued.
Aminolab’s professionals provide the cosmetics industry with extensive laboratory support for the development and registration of cosmetics products. The services given by the department Includes consultations, recommendations for sterilization conditions, packaging tests, stability studies and development of analytical methods.
Project performance is based on years of experience, a broad laboratory infrastructure and advanced instrumentation.
Following is a partial list of products:
Creams, solutions, emulsions, powders, lipsticks, nail polish, aerosols, detergents, gel, cosmetic pencils, hygienic products such as: bandages and additional products according to customer requests.
For more information please feel free to contact us:
Dr. Sara Tal
Tel: 972-8-9303380/81
Fax: 972-8-9303385
sara@aminolab.net
Aminolab’s R&D department specializes in providing GLP R&D laboratory services for the pharmaceutical and biotechnological industry. The R&D department is certified as a GLP laboratory by the EU (European Union 88/320/EEC) and by the ISRAC (Israel Laboratory Accreditation Authority).
An experienced professional team, as well as state of the art equipment, enables Aminolab R&D Department to fulfill our client’s demands, delivering quality with fast turnaround time, provide innovative and professional services, with integrity and reliability while observing all regulatory GLP requirements.
Our customers include established pharmaceutical companies, drug delivery companies, start-up and biopharmaceutical companies.
Aminolab`s R&D Department provides the following services:
• Development and Validation of Analytical methods: drug substance, drug product, impurities and stability indicating
• Pharmacokinetic studies
• Bioequivalence studies
• Stability tests
• Raw material release
• Drug product release
• Drug substance release
State-of-the-Art Equipment and Skilled professional team
The R&D department premises are spacious and contain State-of-the-Art equipment as well as a skilled professional team trained and experienced in the area of pharmaceutical chemistry.
The following instrumentation is available:
› HPLCs equipped with: Fluorescence, EC, PDA, UV, RI
› LC-MS/MS
› GC-MS & GC-MS/MS
› Temperature, humidity and light controlled incubators
Additional services
Aminolab delivers a total solution by offering comprehensive package of analytical services:
• Heavy metals, metals by ICP, EtO, ethanol, OVI, TOC, IR spectrum, analysis following USP BP monographs
• Sterility, microbial limit test, pyrogen (LAL) test, antimicrobial preservative efficacy-challenge test , antimicrobial activity, environmental monitoring, bacteriostasis/fungistasis, growth Promotion test
• Total analysis of pesticides (5 batch analysis)
Comprehensive Bioanalysis studies for clinical trials
Providing exclusive drug development services for more than 15 years, our dedicated global R&D teams provide method development and validation support to pharmaceutical and biotechnology companies, in accordance with regulatory guidelines. For clinical investigations Aminolab has been demonstrating its skills in the area of bioanalysis for clinical trails. Having strong service orientation with an unwavering focus on meeting client needs, being flexible and responsive, Aminolab R&D department helps you to improve your speed to market.
Our service covers Bioanalysis support from Phase I to large-scale Phase III/IV studies.
Whether it's a big global clinical trial or a small local project Aminolab has knowledge intelligently, offering analytical method development and validation with integrated pharmacokinetics (PK) that provide you with the most relevant and concise scientific analysis of study samples provided data to guide critical decisions in product development and enable you to proceed quickly toward the next phase of drug development.
Method Validation
Our dedicated global teams provide method development and validation support for clinical investigations, in accordance with FDA May 2001 guidelines. Our validation criteria are compliant, ensuring you obtain a robust and reliable assay that delivers sensitivity and selectivity.
Pharmacokinetics (PK) services
Aminolab provides the necessary PK modeling for the evaluation of absorption, distribution, metabolism and excretion of new chemical entities.
Data generation and QA
Aminolab takes innovative approaches to provide you with high-quality data, generated on time. We hold on-site QA manager who ensures adherence to analytical methods, SOPs and GLP regulatory obligations and guidelines. The QA manager audits in-process projects, communicates audit results to management, reviews all data, project notebooks and final reports for completeness and accuracy, conducts laboratory inspections and responsible of archives project data in a limited access room under his supervision.
Our laboratory is certified as a GLP laboratory by the EU (European Union 88/320/EEC) and by the local accreditation authority.
Aminolab Ltd.
Weizman Science Park, Ness-Ziona, Israel.
Tel: 972-8-9303307
Fax: 972-8-9303300
www.aminolab.net
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